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The Collapse of the FDA

nytimes.com

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Re: The Collapse of the FDA

#101

Post by pjc50 »

jdross wrote: post #92
LadyCailin wrote: post #87

Earlier quoted context omitted.

It really feels like the US is a failed state at this point, but it just hasn’t had full impact yet. Not really sure how all this destruction (in only half a year!) can be reversed in any meaningful timeframe in the future.

I’m not trying to challenge how you feel, but I’ll note that in my social groups people don’t feel this way, life is good, and they also feel confident that they’re well informed. So I’m open to the possibility that lot of these types of feeling, in both directions depending on the political era, is more dictated by environment and media consumption choices and their versions of doom and gloom than reality

Plenty of people feel that way when they're in Dubai or Qatar. Lovely place, just don't look at the army of migrant workers with no rights who keep it all running.

Re: The Collapse of the FDA

#102

Post by tsimionescu »

monero-xmr wrote: post #38
nine_zeros wrote: post #35

Earlier quoted context omitted.

> Government agencies that spend massive amounts of tax dollars while accomplishing nothing and being net-negative for society. Anyone who has worked for or dealt with the government for extended periods of time will clearly know how fucked it is This is only true of republican governments. Republican-led governments are truly appalling in their spending, and wasteful tax cuts. Democrat governments are far far more e…

[flagged]

You know so little about how the world actually works that it's funny you even try to speak about it.

Society would literally cease to function if the government stopped providing the services that your "friction" funds. Roads, the court system, police, waste and water, defense - these barely scratch the surface of what the US government provides, and yet remove any one of them and it would be enough to bring down the entire economy.

Re: The Collapse of the FDA

#103

Post by wizzwizz4 »

kelseyfrog wrote: post #53
sorcerer-mar wrote: post #20

Earlier quoted context omitted.

Sooo that sounds like there's a whole lot of ways for it to get way, way, way worse. The existence of problems does not imply there cannot be more plentiful, more diverse, and more severe problems in the near future.

If Chesterton's fence doesn't have a working latch, then it's appropriate to remove it entirely.

If Chesterton's fence is intangible and invisible, then it's appropriate to remove it entirely. If it doesn't have a working latch, it doesn't serve as a hard barrier, but it may still serve as a soft barrier, and that may be good enough.

Or, conversely, important things may have been relying on access via the latch-free fence gate: fixing the latch without providing a more appropriate solution to those issues could cause more harm than the benefit you get from "now the fence actually functions as a barrier". (Sure, the latch keeps the wolves out, and stops them picking off the sheep – but it also keeps the sheep away from their only freshwater source, without which most of the sheep are going to die.)

Re: The Collapse of the FDA

#104

Post by Tade0 »

King-Aaron wrote: post #72
pedro_caetano wrote: post #71

Worth reminding everyone that, on top of pharma and food, the FDA also regulates medical devices. Insufficient regulation both on approval _and_ inspection of medical devices (thinking surgical applications and implantables for example) is as impactful on patient safety as drugs.

NeuralLink is suddenly going to get a miraculous green light for broad human trials hey

That's a relatively minor danger. My father, before retirement, was responsible for certifying medical devices. The number of outright scams which reached his desk was off the charts.

Half of that stuff didn't work as advertised, the other was actually dangerous, because it e.g. didn't control dosage.

Re: The Collapse of the FDA

#105

Post by indolering »

Amezarak wrote: post #95
Skates1616 wrote: post #42

Earlier quoted context omitted.

I’m very familiar with this space, specifically parenteral manufacturing. The real challenge lies in the expectations the FDA has set for manufacturing. Over time, the regulatory space has been heavily influenced by academic-driven theoretical scenarios for microbiological contamination. While well-intentioned, these theoretical risks often drive overly stringent requirements that don’t always reflect real-world manu…

https://www.propublica.org/article/fda-drug-loophole-sun-pha... > Digging through company records and test results, they found more evidence of quality problems, including how managers hadn’t properly investigated a series of complaints about foreign material, specks, spots and stains in tablets. > Those unknowns have done little to slow the exemptions. In 2022, FDA inspectors described a “cascade of failure” at one…

But bacteria are all natural!

Re: The Collapse of the FDA

#106

Post by pjc50 »

netsharc wrote: post #93
LadyCailin wrote: post #87

Earlier quoted context omitted.

It really feels like the US is a failed state at this point, but it just hasn’t had full impact yet. Not really sure how all this destruction (in only half a year!) can be reversed in any meaningful timeframe in the future.

As Sarah Chayes said about the "failed state" of Afghanistan: > Afghanistan is often described as a “failed state,” but, in light of the outright thievery on display, Chayes began to reassess the problem. This wasn’t a situation in which the Afghan government was earnestly trying, but failing, to serve its people. The government was actually succeeding, albeit at “another objective altogether”—the enrichment of its o…

> The government was actually succeeding, albeit at “another objective altogether”—the enrichment of its own members.

Indeed. And as soon as the flow of foreign money propping the whole thing up was cut off, they vanished like melting snow across the border.

Corruption endangers security in all sorts of ways. This came up at the start of the Russian invasion of Ukraine, when it became apparent that maintenance money (and in some cases entire pieces of equipment) had been diverted, resulting in operational failure. The US Navy had a corruption scandal a while ago too ("Fat Leonard").

> to declare that the government may commit crimes in order to secure the conviction of a private criminal

Not even conviction, just straight up execution. The lesson of the BLM backlash was that, no, really the US public demanded that the police had the right to execute citizens in the street without accountability.

Re: The Collapse of the FDA

#107

Post by UncleMeat »

clumsysmurf wrote: post #8

“FDA’s war on public health is about to end,” Kennedy wrote. “This includes its aggressive suppression of psychedelics, peptides, stem cells, raw milk, hyperbaric therapies, chelating compounds, ivermectin, hydroxychloroquine, vitamins, clean foods, sunshine, exercise, nutraceuticals and anything else that advances human health and can’t be patented by Pharma." Anyone know what chelating compounds he is talking about…

I find this quote so fascinating. Who makes ivermectin and hydroxychloroquine? Pharma companies! Who makes vitamins and supplements? Massive corporations! Is there a single doctor on the planet who doesn't tell their patients that sunshine and exercise are good for them?

Re: The Collapse of the FDA

#108

Post by sorcerer-mar »

monero-xmr wrote: post #34
sorcerer-mar wrote: post #31

Earlier quoted context omitted.

Anyone who has worked in drug development knows how vital FDA is. The FDA costs taxpayers less than $4 billion per year. If FDA is a net negative, next time you need a medication you're aware you can go participate in a Phase I study, and get paid to take a cutting edge drug for it? Why bother looking at the stuff on the medicine shelf that costs you money? Can you give us all an idea of your experience working with…

Should allow pharma to sell drugs to the market. Allow people to sue if they are harmed. Do not care about a government agency preventing access to new drugs. They can gatekeep government funds at best, limiting Medicaid / Medicare to those that want to pass their hoops My experience is in selling tech to government. Disgusting and corrupt.

Tell me: how do you prove that a drug hurt you?

Spoiler alert: you cannot.

The reason clinical trials are so expensive and complicated is because it's extremely hard to isolate signal of "what is this drug doing to people."

So on what basis would you possibly sue a company?

As another commenter said, we have an entire industry of the form you desire: supplements. Go take them to treat your next illness so you can really experience the creme de la creme that FDA is apparently keeping from you. Good luck suing for lack of effectiveness or for any harms you encounter.

Re: The Collapse of the FDA

#109

Post by sorcerer-mar »

andrewflnr wrote: post #37
sorcerer-mar wrote: post #23

Earlier quoted context omitted.

What's oppressive about FDA? Be specific.

They obviously weren't referring "specifically" to the FDA at that point.

It seems to me they were referring to FDA as a member among other "oppressive regimes" that fail in this way.
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